| Primary | Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | Pain intensity as assessed by the NRS for worst pain in the past 7 days using a 0-10 scale (0 = "no pain" and 10 = "worst pain imaginable") | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 | Enhanced Educational Control Group (CG-2) | Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups. Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0007.4± 1.7
- OG0017.0± 1.8
- OG0027.3± 1.7
|
|
| |
| Primary | Pain Intensity as Assessed by the Numeric Rating Scale (NRS) | Pain intensity as assessed by the NRS for worst pain in the past 7 days using a 0-10 scale (0 = "no pain" and 10 = "worst pain imaginable") | Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm. | Posted | | Mean | Standard Deviation | score on a scale | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Primary | Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | Pain interference is assessed by the Brief Pain Inventory pain interference subscale, which uses a 0-10 scale (0 = "does not interfere" and 10 = "completely interferes"). | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 |
|
| Primary | Pain Interference as Assessed by the Brief Pain Inventory-short Form Pain Interference Subscale | Pain interference is assessed by the Brief Pain Inventory pain interference subscale, which uses a 0-10 scale (0 = "does not interfere" and 10 = "completely interferes"). | Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm. | Posted | | Mean | Standard Deviation | score on a scale | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Primary | Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, is used to assess the impact of back pain on their daily functioning. The score ranges from 0 (no disability) to 24 (maximum disability). | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 |
|
| Primary | Physical Function as Assessed by the Roland Morris Disability Questionnaire (RMDQ) | The Roland Morris Disability Questionnaire (RMDQ), 24-item measure, is used to assess the impact of back pain on their daily functioning. The score ranges from 0 (no disability) to 24 (maximum disability). | Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 18 in the Control arm. | Posted | | Mean | Standard Deviation | score on a scale | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | Number of Participants Who Use Opioids | | | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 | Enhanced Educational Control Group (CG-2) | Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups. Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet. |
|
| Secondary | Number of Participants Who Use Opioids | | Data were not collected for 17 in the T-APA arm, 29 in the NT-APA arm, and 20 in the control arm. | Posted | | Count of Participants | | Participants | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 | Enhanced Educational Control Group (CG-2) |
|
| Secondary | APA Treatment Satisfaction as Assessed by Satisfaction Survey | Satisfaction is assessed using a 5-point numeric rating scale:
- - Completely satisfied
- - Somewhat satisfied
- - Neither satisfied nor dissatisfied
- - Somewhat dissatisfied
- - Very dissatisfied
| Data were not collected for 11 in the T-APA arm and 17 in the NT-APA arm. These data were not collected for any of the 89 in the control arm, as they did not receive the APA treatment. | Posted | | Mean | Standard Deviation | score on a scale | | immediately post intervention (1 month after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | APA Treatment Satisfaction as Assessed by Satisfaction Survey | Satisfaction is assessed using a 5-point numeric rating scale:
- - Completely satisfied
- - Somewhat satisfied
- - Neither satisfied nor dissatisfied
- - Somewhat dissatisfied
- - Very dissatisfied
| Data were not collected for 17 in the T-APA arm and 29 in the NT-APA arm. These data were not collected for any of the 89 in the control arm, as they did not receive the APA treatment. | Posted | | Mean | Standard Deviation | score on a scale | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, anxiety. The raw score on the anxiety subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater anxiety. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, an anxiety T-score of 40 is one SD better than average in terms of anxiety. A T-score below 55 is indicative of anxiety within normal limits. | | Posted | | Mean | Standard Deviation | T-score | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Anxiety | The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, anxiety. The raw score on the anxiety subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater anxiety. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, an anxiety T-score of 40 is one SD better than average in terms of anxiety. A T-score below 55 is indicative of anxiety within normal limits. | Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm. | Posted | | Mean | Standard Deviation | T-score | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | |
|
| Secondary | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, depression. The raw score on the depression subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater depression. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a depression T-score of 40 is one SD better than average in terms of depression. A T-score below 55 is indicative of depression within normal limits. | | Posted | | Mean | Standard Deviation | T-score | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Depression | The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, depression. The raw score on the depression subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater depression. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a depression T-score of 40 is one SD better than average in terms of depression. A T-score below 55 is indicative of depression within normal limits. | Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm. | Posted | | Mean | Standard Deviation | T-score | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA |
|
| Secondary | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance | The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, sleep disturbance. The raw score on the sleep disturbance subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater sleep disturbance. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a sleep disturbance T-score of 40 is one SD better than average in terms of sleep disturbance. A T-score below 55 is indicative of sleep disturbance within normal limits. | | Posted | | Mean | Standard Deviation | T-score | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) - Sleep Disturbance | The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a 29-item profile instrument that can be used to assess seven subscales of health quality of life (QOL) for each of 7 domains-this outcome measure reports one of the 7 domains, sleep disturbance. The raw score on the sleep disturbance subscale is converted to a standardized T-score. T-score is reported here, and it ranges from 0 to 100, with a higher PROMIS T-score representing more of the concept being measured, that is, greater sleep disturbance. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; therefore, a sleep disturbance T-score of 40 is one SD better than average in terms of sleep disturbance. A T-score below 55 is indicative of sleep disturbance within normal limits. | Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 20 in the Control arm. | Posted | | Mean | Standard Deviation | T-score | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA |
|
| Secondary | Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | The fear-avoidance beliefs questionnaire (FABQ) focuses on participant's beliefs about how physical activity and work affect their pain. The questionnaire consists of 16 items in which a participant rates their agreement with each statement on a 7-point Likert scale where 0 = completely disagree and 6 =completely agree. The total score ranges from 0 to 96. A higher score indicates more strongly held fear-avoidance beliefs. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | Fear-Avoidance as Assessed by the Fear-avoidance Beliefs Questionnaire (FABQ) | The fear-avoidance beliefs questionnaire (FABQ) focuses on participant's beliefs about how physical activity and work affect their pain. The questionnaire consists of 16 items in which a participant rates their agreement with each statement on a 7-point Likert scale where 0 = completely disagree and 6 =completely agree. The total score ranges from 0 to 96. A higher score indicates more strongly held fear-avoidance beliefs. | Data were not collected for 11 in the T-APA arm, 29 in the NT-APA arm, and 21 in the Control arm. | Posted | | Mean | Standard Deviation | score on a scale | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of13 items. Participants were asked to reflect on past painful experiences and to indicate to which degree he/she experienced symptoms such as helplessness or rumination when feeling pain. This is a 0-4 Likert scale (score sum 0-52) with responses ranging from "not at all" to "all the time," with higher scores indicate stronger catastrophizing. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
|
| Secondary | Pain Catastrophizing as Assessed by the Pain Catastrophizing Scale (PCS) | The PCS was included to detect exaggerated and negative interpretations of pain. It is a self-report scale that consists of13 items. Participants were asked to reflect on past painful experiences and to indicate to which degree he/she experienced symptoms such as helplessness or rumination when feeling pain. This is a 0-4 Likert scale (score sum 0-52) with responses ranging from "not at all" to "all the time," with higher scores indicate stronger catastrophizing. | Data were not collected for 11 in the T-APA arm, 19 in the NT-APA arm, and 21 in the Control arm. | Posted | | Mean | Standard Deviation | score on a scale | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
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| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). |
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| Secondary | Memory as Assessed by the Stroop Test | T-score will be reported, with a range of 0-100, with a higher score indicating better memory. | Data were not collected from any participant for this outcome measure. | Posted | | | | | | Baseline | | | | ID | Title | Description |
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| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 | Enhanced Educational Control Group (CG-2) |
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| Secondary | Memory as Assessed by the Stroop Test | T-score will be reported, with a range of 0-100, with a higher score indicating better memory. | Data were not collected from any participant for this outcome measure. | Posted | | | | | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
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| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 |
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| Secondary | Relaxation as Assessed by Relaxation Response | | Data were not collected from any participant for this outcome measure. | Posted | | | | | | Baseline | | | | ID | Title | Description |
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| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 | Enhanced Educational Control Group (CG-2) | Participants in the enhanced educational control group will be given the cLBP educational booklet and visit the office weekly for assessment (i.e., blood draws and questionnaires), which is the same schedule as that for the APA groups. Enhanced Educational Control Group (CG-2): No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet. |
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| Secondary | Relaxation as Assessed by Relaxation Response | | Data were not collected from any participant for this outcome measure. | Posted | | | | | | 1 month post completion of the treatment (2 months after baseline) | | | | ID | Title | Description |
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| OG000 | T-APA | Patients with active points related to cLBP. Will receive acupressure within the two zones for cLBP located on the front and back of the ear and three points known for alleviating stress and pain. Target ear points related to chronic low back pain (T-APA): Light touch using vaccaria seeds on specific points of the ear. | | OG001 | NT-APA | The same procedure for APA will be applied but the tapes/seeds will be placed on five different ear points, comprising mouth, stomach, duodenum, internal ear, and tonsil. These points are chosen for the non-target ear points of APA treatment for two reasons. First, they are distinct from the zones of the ear (and the points therein) associated with the lower back, and correspond to body regions in which the participant is usually pain-free. Second, they are equivalent in number to those points used in the APA treatment group. Non-Target ear Points not related to chronic low back pain (NT-APA): Light touch using vaccaria seeds on different points of the ear (compared to the APA group). | | OG002 | Enhanced Educational Control Group (CG-2) | |
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